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Sponsored by: |
National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00064116 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without rituximab in treating patients with non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens and rituximab to see how well they work compared to four different combination chemotherapy regimens alone in treating patients with non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: CHOP regimen Drug: EPOCH regimen Drug: bleomycin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: methotrexate Drug: mitoxantrone hydrochloride Drug: prednisolone Drug: prednisone Drug: rituximab Drug: vincristine sulfate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Randomized Intergroup Trial of First Line Treatment for Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma With a CHOP-Like Chemotherapy Regimen With or Without the Anti-CD20 Antibody Rituximab (IDEC-C2B8) |
Study Start Date: | May 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, bulky disease (no vs yes), International Prognostic Index score (0 vs 1), and chemotherapy (CHOP vs CHOEP vs PMitCEBO vs MACOP-B). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive 1 of the following chemotherapy regimens according to participating country:
Arm II: Patients receive arm I regimens (according to participating country) and rituximab as follows:
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 820 patients will be accrued for this study within approximately 2 years.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma according to REAL classification
International Prognostic Index (IPI) score of 0 or 1
Score 0 defined by all of the following:
Score 1 defined by 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Canada, Alberta | |
Cross Cancer Institute at University of Alberta | |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Tom Baker Cancer Centre - Calgary | |
Calgary, Alberta, Canada, T2N 4N2 | |
Canada, New Brunswick | |
Saint John Regional Hospital | |
Saint John, New Brunswick, Canada, E2L 4L2 | |
Canada, Newfoundland and Labrador | |
Newfoundland Cancer Treatment and Research Foundation | |
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6 | |
Canada, Nova Scotia | |
Nova Scotia Cancer Centre | |
Halifax, Nova Scotia, Canada, B3H 1V7 | |
Canada, Ontario | |
Cancer Centre of Southeastern Ontario at Kingston General Hospital | |
Kingston, Ontario, Canada, K7L 5P9 | |
Grand River Regional Cancer Centre at Grand River Hospital | |
Kitchner, Ontario, Canada, N2G 1G3 | |
London Regional Cancer Program at London Health Sciences Centre | |
London, Ontario, Canada, N6A 465 | |
Northeastern Ontario Regional Cancer Centre | |
Sudbury, Ontario, Canada, P3E 5J1 | |
Ottawa Hospital Regional Cancer Centre - General Campus | |
Ottawa, Ontario, Canada, K1H 8L6 | |
St. Catharines General Hospital at Niagara Health System | |
St. Catharines, Ontario, Canada, L2R 5K3 | |
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre | |
Toronto, Ontario, Canada, M4N 3M5 | |
Trillium Health Centre - Mississauga Site | |
Mississauga, Ontario, Canada, L5B 1B8 | |
Canada, Quebec | |
Centre Hospitalier de l'Universite de Montreal | |
Montreal, Quebec, Canada, H2L 4MI | |
Hopital Charles Lemoyne | |
Greenfield Park, Quebec, Canada, J4V 2H1 | |
Hopital du Saint-Sacrement, Quebec | |
Quebec City, Quebec, Canada, G1S 4L8 |
Study Chair: | Kevin Imrie, MD | Edmond Odette Cancer Centre at Sunnybrook |
Study ID Numbers: | CDR0000309053, CAN-NCIC-LY9, ROCHE-CAN-NCIC-LY9, MINT-M39045 |
Study First Received: | July 8, 2003 |
Last Updated: | January 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00064116 |
Health Authority: | United States: Federal Government |
stage I adult diffuse large cell lymphoma contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma |
Prednisone Methylprednisolone Lymphoma, small cleaved-cell, diffuse Prednisolone acetate Cyclophosphamide Etoposide phosphate Lymphoma, large-cell Lymphoma, B-Cell Methotrexate Lymphoma Etoposide Immunoglobulins Methylprednisolone Hemisuccinate Lymphoma, Large B-Cell, Diffuse |
Immunoproliferative Disorders Rituximab Methylprednisolone acetate Vincristine Bleomycin Doxorubicin Folic Acid Lymphatic Diseases Antibodies B-cell lymphomas Prednisolone Mitoxantrone Lymphoproliferative Disorders Lymphoma, Non-Hodgkin |
Antimetabolites Anti-Inflammatory Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Antibiotics, Antineoplastic Hormones Sensory System Agents Therapeutic Uses Abortifacient Agents Analgesics |
Alkylating Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Neoplasms |